The U.S. Food and Drug Administration (FDA) on Friday approved Biogen and Sage Therapeutics oral pill to treat postpartum depression (PPD) in…
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Global MarketIntellectual Property (IP)Patents
Latest Global Patent News: Canada Implements Patent Term Adjustment in Diverse Sectors, Encompassing Agriculture, Chemicals, and Pharmaceuticals.
by adminby adminOverview To make up for arbitrary delays in the issuing of patents by the Canadian Intellectual Property Office, Canada has passed laws…
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2023 ApprovalsMarch 2023Pharma ApprovalsU.S FDA
March 2023 Approval Update – DAYBUE™ (Trofinetide) from Acadia Pharmaceuticals has Received U.S. FDA Approval for the Treatment of Rett syndrome in Adult and Paediatric patients Two years of age and older.
by adminby adminSynopsis First and only approved therapy for Rett syndrome, a rare, neurodevelopmental disorder, which affects 6,000 to 9,000 patients in the U.S.…
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Astellas’ VEOZAH™ (Fezolinetant) Gets U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
by adminby adminOn May 12, the U.S. Food and Drug Administration (FDA) approved VEOZAHTM (Fezolinetant), 45 mg once daily for the treatment of moderate…
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Lexicon’s INPEFA™(Sotagliflozin) Notch FDA Approval for Treatment of Heart Failure
by adminby adminSummary:- INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or…
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RegulatoryU.S FDA
Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (Terlipressin) for Injection for the Treatment of Hepatorenal Syndrome (HRS)
by adminby adminHighlights: Terlivaz is the first and only FDA-approved treatment for adults with HRS involving rapid reduction in kidney function. Terlivaz is expected…
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RegulatoryU.S FDA
Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON™ (eflapegrastim-xnst) Injection
by adminby adminSummary: First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years ROLVEDON™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and…
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Boehringer IngelheimRegulatoryU.S FDA
Boehringer’s Spevigo (spesolimab) Bags First FDA Approval for Rare Skin Disease, for Generalized Pustular Psoriasis (GPP)
by adminby adminSynopsis: German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised…
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RegulatoryU.S FDA
Incyte Announces FDA Approval of Pemazyre® (Pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
by adminby adminSynopsis : This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable…
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RegulatoryU.S FDA
Axsome Therapeutics Auvelity(dextromethorphan HBr -bupropion HCl) Becomes the First FDA-Approved Oral NMDA for Major Depression
by adminby adminSummary: The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral…
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